MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PROGRASP FORCEPS; ENDOSCOPIC INSTRUMENT

Model Number 420093-12

Device Problem Device Issue (2379)

Patient Problem Tissue Damage (2104)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

The prograsp forceps instrument was returned to intuitive surgical, inc.(isi) and evaluated.Upon visual and microscopic inspection, no damage was found to the instrument's wrist assembly.No sharp edges/ burrs were found.No broken or frayed cable was found at the instrument's wrist.Manual input the disk knob exhibited intuitive motion.The instrument was placed and driven on a da vinci in-house system.The instrument passed recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly and performed grip function without any issues.No interference/issues occurred with the objects and the distal pulley system.No difficulty was observed while removing and installing the instrument on a system arm.Levers were still present on the instrument and were easily depressed to remove the instrument during disengagement of the instrument with various cannulas.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2018.No related system errors were found to have occurred during the surgical procedure based on the available system logs.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, bowel tissue allegedly got stuck around the distal pulley system of the prograsp forceps instrument.The patient reportedly sustained a small bowel tear during attempts to remove the stuck tissue.As a result, the bowel tear was repaired with one suture.However, the root cause of the operative complication is unknown.The prograsp forceps instrument was returned to isi and no issues were found with an evaluation of the instrument.

Event Description

It was reported that during a da vinci-assisted prostatectomy procedure, bowel serosa allegedly got stuck in the distal pulley system of the prograsp forceps instrument.The event occurred after the surgeon had reportedly used the instrument to retract bowel out of the pelvis.In order to retrieve the prograsp forceps instrument, the surgeon had to tease out the stuck tissue from the instrument's pulley system using a monopolar curved scissors (mcs) instrument.During this process, a small tear was identified on the bowel serosa.The surgeon repaired the bowel defect with a single suture.The prograsp forceps instrument was replaced with another instrument and the surgical procedure was completed.No post-operative complications were reported.

• Brand Name: PROGRASP FORCEPS
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7251674
• MDR Text Key: 99351341
• Report Number: 2955842-2018-00084
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420093-12
• Device Lot Number: N10170424 095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 56